Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80689–80712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2001
MEDITHERM MED2000
K003332 · LHQ
Meditherm, Inc.
Radiology · 120d
Cleared Feb 21, 2001
MEDRELIEF
K003507 · GZJ
Healthonics, Inc.
Neurology · 100d
Cleared Feb 21, 2001
AURORA
K003651 · LNH
Aurora Imaging Technology, Inc.
Radiology · 86d
Cleared Feb 21, 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K003789 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 75d
Cleared Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · HIF
Stryker Corp.
Obstetrics & Gynecology · 75d
Cleared Feb 21, 2001
EZ-HCG URINE(PREGNANCY TEST)
K003856 · JHI
Biomerica, Inc.
Chemistry · 70d
Cleared Feb 21, 2001
NUCAMMA BI90
K003882 · KPS
Is2 Research, Inc.
Radiology · 68d
Cleared Feb 21, 2001
PHOSPHORUS REAGENT
K003912 · CEO
Jas Diagnostics, Inc.
Chemistry · 64d
Cleared Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT...
K003996 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 21, 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B)...
K004000 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 21, 2001
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
K010210 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 29d
Cleared Feb 21, 2001
CHALLENGER DIRECT COMPOSITE
K010219 · EBF
International Dental Research
Dental · 28d
Cleared Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Feb 21, 2001
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K010374 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared Feb 21, 2001
TE ME NA EPIDURAL CATHETER
K991259 · BSO
Te ME NA S.A.R.L.
Anesthesiology · 680d
Cleared Feb 20, 2001
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
K003470 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 104d
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608 · HGI
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · HBC
Aesculap, Inc.
Neurology · 90d
Cleared Feb 20, 2001
PLGA PIN, MODEL...
K003659 · HTY
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Dade Behring, Inc.
Hematology · 67d
Cleared Feb 20, 2001
TOTAL BILIRUBIN REAGENT
K003892 · CIG
Intersect Systems, Inc.
Chemistry · 64d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Dade Behring, Inc.
Chemistry · 28d
Cleared Feb 16, 2001
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
K001916 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 238d